Determination of related substances of zolmitriptan tablets by HPLC and study of quality evaluation / 中国药师

ABSTRACT

Objective To evaluate the quality of zolmitriptan tablets,establish an HPLC method for the determination of related substances in zolmitriptan tablets,improve the quality standard,and provide technical support for drug regulation.Methods The Superlco Ascentis Express90 Phenol Hexy chromatography column(10 cm×3.0 mm,2.7 μm)was recommended.The mobile phase was phosphate buffer containing sodium hexanesulfonate(pH 2.0)-acetonitrile,with gradient elution.The detection wavelength was 220 nm,the flow rate was 0.8 mL·min-1,the column temperature was 40℃,and the injection amount is 10 μL.The method was used to test 40 batches of zolmitriptan tablet samples and substance taken from all over the country.Results Zomitriptan had a goog linear relationship in the range of 0.840-1.260 μg·mL-1(r=0.999 9),and its detection limit was 1 ng.The detection limits for impurities 1-5 were 0.11,0.52,10.91,1.04 and 2.18 ng,respectively.Conclusion The method is specific,and was used to evaluate the quality of commercially available zolmitriptan tablets.The critical control points and the effect of coating technology on the quality of zolmitriptan tablets were found,and it is suggested that the storage condition of the product should be defined as"cool and dark place".